Cleared Traditional

K191149 - CARESCAPE B650

K191149 is an FDA 510(k) clearance for CARESCAPE B650, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K191149 · GE Healthcare Finland Oy · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2020
Decision
266d
Days
Class 2
Risk

K191149 is an FDA 510(k) clearance for the CARESCAPE B650. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on January 21, 2020 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K191149

510(k) Number K191149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2019
Decision Date January 21, 2020
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K191149.
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
K200494 · Ge Healthcare · Mar 2020
Carescape B850
K191323 · GE Healthcare Finland Oy · Jan 2020
CARESCAPE B450
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Carescape One
K190008 · Ge Healthcare · Dec 2019
ZOLL Arrhythmia Management Sysyem
K190939 · Zoll Manufacturing Corporation · Dec 2019
C50 and C80 Multi-parameter Patient Monitor
K191106 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2019